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Efficacy and safety of direct oral factor Xa inhibitors compared with warfarin in patients with morbid obesity: a single-centre, retrospective analysis of chart data
The Lancet Haematology ( IF 24.7 ) Pub Date : 2019-05-24 , DOI: 10.1016/s2352-3026(19)30086-9
Margarita Kushnir , Yun Choi , Ruth Eisenberg , Devika Rao , Seda Tolu , Jackson Gao , Wenzhu Mowrey , Henny H Billett

Background

Because studies of direct oral anticoagulants in patients with venous thromboembolism and non-valvular atrial fibrillation have had minimal representation of morbidly obese patients (ie, body-mass index [BMI] ≥40 kg/m2), their efficacy and safety in this population are unclear. We investigated whether apixaban and rivaroxaban are as effective and safe as warfarin in morbidly obese patients.

Methods

We did a single-centre, retrospective analysis of chart data for all adult patients aged at least 18 years at Montefiore Medical Center (Bronx, NY, USA) with a BMI of at least 40 kg/m2 who were prescribed apixaban, rivaroxaban, or warfarin for either venous thromboembolism or atrial fibrillation between March 1, 2013, and March 1, 2017. Patients who had both venous thromboembolism and atrial fibrillation were excluded, as were patients with indications other than atrial fibrillation and venous thromboembolism. Outcomes of recurrent venous thromboembolism, stroke, and bleeding were measured from the first prescription date to the earliest of a thrombotic event, medication discontinuation, death, or end of study on June 30, 2017. Analyses were stratified by anticoagulation indication and adjusted for comorbidities, CHA2DS2-VASc score, and age where appropriate. Outcome rates were compared using Pearson's χ2 or Fisher's exact test. Time-to-event analyses accounting for length of follow-up were used to compare risks of outcomes.

Findings

We obtained data for 795 patients: 150 prescribed apixaban, 326 rivaroxaban, and 319 warfarin. In 366 patients prescribed an anticoagulant for venous thromboembolism, the incidence of recurrent venous thromboembolism was similar between the apixaban, rivaroxaban, and warfarin cohorts (1/47 [2·1%, 95% CI 0·0–6·3], 3/152 [2·0%, 0·0–4·2], and 2/167 [1·2%, 0·0–2·9], respectively; p=0·74). Incidence of major bleeding in this patient group was also similar between the treatment cohorts (1/47 patients on apixaban [2·1%, 95% CI 0·0–6·3], 2/152 on rivaroxaban [1·3%, 0·0–3·1], and 4/167 on warfarin [2·4%, 0·1–4·7]; p=0·77). In 429 patients prescribed an anticoagulant for atrial fibrillation, incidence of stroke was similar between the treatment cohorts (1/103 patients on apixaban [1·0%, 95% CI 0·0–2·9], 4/174 on rivaroxaban [2·3%, 0·1–4·5], and 2/152 on warfarin [1·3%, 0·0–3·1], p=0·71). In this patient group, major bleeding occurred in 3/103 patients on apixaban (2·9%, 95% CI 0·0–6·2), 5/174 on rivaroxaban (2·9%, 0·4–5·4), and 12/152 on warfarin (7·9%, 3·6–12·2); p=0·063. Time-to-event analyses showed that risk of all outcomes in patients with venous thromboembolism, and stroke and composite bleeding in patients with atrial fibrillation, were similar between the anticoagulant cohorts.

Interpretation

Our retrospective study provides further evidence of similar efficacy and safety between the direct oral anticoagulants apixaban and rivaroxaban, and warfarin in morbidly obese patients with atrial fibrillation and venous thromboembolism. These data, if confirmed in prospective studies, might enable patients with a BMI of at least 40 kg/m2 to benefit from more convenient, and possibly safer, anticoagulants.

Funding

None.



中文翻译:

直接口服Xa因子抑制剂与华法林相比在病态肥胖中的疗效和安全性:图表数据的单中心回顾性分析

背景

因为对患有静脉血栓栓塞和非瓣膜性心房颤动的患者直接口服抗凝剂的研究对病态肥胖患者的代表很小(即,身体质量指数[BMI]≥40 kg / m 2),所以它们在该人群中的疗效和安全性还不清楚。我们研究了在病态肥胖患者中阿哌沙班和利伐沙班是否与华法林一样有效和安全。

方法

我们对BMI至少为40 kg / m 2的Montefiore医学中心(美国纽约州布朗克斯)所有年龄至少18岁的成年患者进行了单中心回顾性图表数据分析。在2013年3月1日至2017年3月1日之间因静脉血栓栓塞或房颤而开具阿哌沙班,利伐沙班或华法林的处方。除静脉血栓栓塞和房颤的患者外,除房颤和房颤以外还有其他适应症的患者均被排除在外静脉血栓栓塞。从首次开处方日期到血栓形成事件,停药,死亡或研究终止最早日期(从2017年6月30日)开始,测量复发性静脉血栓栓塞,中风和出血的结果。根据抗凝适应症对分析进行分层,并根据合并症进行调整,CHA 2 DS 2 -VASc得分以及适当的年龄。结果速率用Pearson的χ相比2或费舍尔的精确测试。事件发生时间分析考虑了随访时间,用于比较结局风险。

发现

我们获得了795例患者的数据:150例处方的阿哌沙班,326例利伐沙班和319种华法林。在366例为静脉血栓栓塞开了抗凝药的患者中,阿哌沙班,利伐沙班和华法林组的复发性静脉血栓栓塞发生率相似(1/47 [2·1%,95%CI 0·0-6·3],3分别为/ 152 [2·0%,0·0-4·2]和2/167 [1·2%,0·0-2·9]; p = 0·74)。在两个治疗组之间,该患者组的大出血发生率也相似(阿哌沙班为1/47例[2·1%,95%CI 0·0-6·3],利伐沙班为2/152 [1·3%] ,华法林[0·0-3·1]和4/167 [2·4%,0·1-4·7]; p = 0·77)。在429例针对房颤使用抗凝药的患者中,各治疗组之间的卒中发生率相似(阿哌沙班的1/103例患者[1·0%,利伐沙班的1/5的CI为95%CI 0·0-2·9],利伐沙班的4/174 [ 2·3%,0·1-4–5],和华法林[2/152] [1·3%,0·0-3·1],p = 0·71)。在该患者组中,在阿哌沙班中有3/103例患者发生大出血(2·9%,95%CI 0·0-6·2),在利伐沙班中有5/174患者(2·9%,0·4–5· 4),以及关于华法林的12/152(7·9%,3·6-12·2);p = 0·063。事件发生时间分析表明,在抗凝剂组之间,静脉血栓栓塞患者的所有结局风险以及房颤患者的中风和复合性出血风险相似。

解释

我们的回顾性研究提供了进一步的证据,证明直接口服抗凝药apixaban和rivaroxaban与华法林在患有房颤和静脉血栓栓塞的病态肥胖患者中具有相似的疗效和安全性。如果这些数据在前瞻性研究中得到证实,则可能使BMI至少为40 kg / m 2的患者受益于更方便,可能更安全的抗凝剂。

资金

没有。

更新日期:2019-05-27
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